PDA TR 54-5

Technical Report No. 54-5 (TR 54-5) Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems

Parenteral Drug Association , 05/01/2017

Publisher: PDA

File Format: PDF

$162.00$325.00


PDA's Technical Report No. 54-5, Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems provides practical guidance on how to manage quality risks throughout the manufacturing system lifecycle and illustrates concepts through two case studies. The information in this technical report is applicable to both new and existing manufacturing systems used in clinical, commercial manufacturing, drug substance (API), drug product, packaging and warehousing and critical utility systems. It focuses on manufacturing systems, which can potentially impact product quality.

More PDA Standards PDF

PDA TR 22

PDA TR 22

$162.00 $325.00

PDA TR 52

PDA TR 52

$162.00 $325.00

PDA TR 53

PDA TR 53

$162.00 $325.00

PCI MNL-141-12

PCI MNL-141-12

$16.00 $33.00